510(k) · Cleared
ClearedPasco Mic and Mic/ID Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pasco Laboratories, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Aug 26, 1999 after a 79-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Aug 26, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK991925 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK031727 Pasco Mic and Mic/ID Panels, GemifloxacinPasco Laboratories, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK033119 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991925 | Pasco Mic and Mic/ID Panels | Pasco Laboratories, Inc. | 1999 | — |
| +1 | K031727 | Pasco Mic and Mic/ID Panels, Gemifloxacin | Pasco Laboratories, Inc. | 2003 | — |
| +1 | K033119 | Pasco Mic and Mic/ID Panels | Pasco Laboratories, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWY device
- #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031727 (Pasco Laboratories, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerabic and facultative anaercbic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of Amoxicillin/Clavulanic Acid to Pasco…
Read the full statement (133 words)
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerabic and facultative anaercbic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of Amoxicillin/Clavulanic Acid to Pasco panels at concentrations of 0.015/0.0075 to 8/4 mcg/ml for use in determining the susceptibility of & prneumoniae and non-pneumococcal streptococci.
With amoxicillin/clavulanic acid, antimicrobial activity is due to amoxicillin, so the strains susceptible to amoxicillin are fully susceptible to amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (Augmentin) is not indicated for treating infections due to S. pneumoniae, S. pyogenes and viridans group streptococci. However, in-vitro susceptibility data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991925: Pasco Mic and Mic/ID Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026